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New treatment option for Sub-arachnoid Haemorrhage
Official title Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
ClinicalTrials.gov ID: NCT05664191
What this study is testing
What is Levosimendan?
Levosimendan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sub-arachnoid haemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sub-arachnoid haemorrhage (SAH) are often due to ruptured intracerebral aneurysms and are associated with an importante morbi-mortality. SAH are often complicated by delayed cerebral ischemia (DCI) potentially due to cerebral vasospasm (CVS).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- All adult patients (18 to 75 years old),
- hospitalized in surgical intensive care at Lariboisière Hospital for subarachnoid haemorrhage of aneurysmal origin
- WFNS clinical score of I to IV and a mFisher score of 3 or 4.
You likely can't join if
- pregnant women
- contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension (mean arterial pressure less than 65 mmHg)...
- severe renal failure (creatinine clearance \< 30 ml/min)
- severe hepatic failure (signs of hepatic encephalopathy) or chronic liver disease
- history of torsades de pointes
- pre-existing severe neurovascular pathologies.
See the full eligibility criteria
- All adult patients (18 to 75 years old),
- hospitalized in surgical intensive care at Lariboisière Hospital for subarachnoid haemorrhage of aneurysmal origin
- WFNS clinical score of I to IV and a mFisher score of 3 or 4.
- pregnant women
- contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension (mean arterial pressure less than 65 mmHg), tachycardia (heart rate greater than 120 bpm), cardiac mechanical...
- severe renal failure (creatinine clearance \< 30 ml/min)
- severe hepatic failure (signs of hepatic encephalopathy) or chronic liver disease
- history of torsades de pointes
- pre-existing severe neurovascular pathologies.
- Moribund patients.
- Patient not affiliated to social security
- Patient participating in another treatment research
- Patients under legal guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.